FDA.reportPublic FDA data

Steelco

Primary DI
08051520011337
Brand
Steelco
Company
STEELCO SPA
Model
ED 100/1
Catalog number
ED 100/1
Device description
This device drying cabinet dries and stores flexible endoscopes keeping them in aseptic conditions while waiting for the next patient.
Published
2025-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JRJUnit, Drying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRJUnit, DryingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051520011337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051520011337080515200113378051520011337

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope drying/storage cabinetAn electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37ยบ Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428717469
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051520024108SteelcoTW 3000/2TW 3000/22026-05-26
08051520022876SteelcoDS 1000 2SDS 1000 2S2026-04-17
08051520022852SteelcoDS 1000 2SDS 1000 2S2026-03-27
08051520022869SteelcoDS 1000 2SDS 1000 2S2026-02-04
08051520021176SteelcoDS 1000 2SDS 1000 2S2025-10-28
08051520021770SteelcoLC 80/3LC 80/32025-09-24
08051520021763SteelcoLC 80/2LC 80/22025-09-16
08051520021473SteelcoTW 3000/2TW 3000/22025-07-24
08051520021480SteelcoLC 80/2LC 80/22025-07-24
08051520020957SteelcoDS 1000 2SDS 1000 2S2025-06-30
08051520021350SteelcoDS 1000 1SDS 1000 1S2025-06-18
08051520021145SteelcoID 300/1ID 300/12025-05-22
08051520021190SteelcoDS 1000 N1SDS 1000 N1S2025-05-22
08051520021169SteelcoDS 1000 2SDS 1000 2S2025-05-08
08051520020940SteelcoDS 1000 2SDS 1000 2S2025-05-05
08051520021022SteelcoAD 400/2AD 400/22025-04-22
08051520020797SteelcoDS 1000 NDS 1000 N2025-04-10
08051520020667SteelcoAD 400/2AD 400/22025-03-24
08051520020636SteelcoBP 100 HSEBP 100 HSE2025-03-20
08051520019623SteelcoID 300/2ID 300/22025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20840113298758CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-20
10840113298638CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113299482CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298642CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298765CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298772CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298796CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298802CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298819CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298895CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298901CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113298994CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299007CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299014CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299021CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299052CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299083CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299090CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299106CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299120CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
20840113299151CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-13
10840113298928CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
10840113298980CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298932CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298949CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298956CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298963CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113298970CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
20840113299168CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10
00814707023824CygnusASPEN SURGICAL PRODUCTS, INC.JRJ2026-04-10